Methods for managing weight loss and body mass

ABSTRACT

The invention provides methods for promoting weight loss by an animal, promoting weight loss by an animal while preventing or minimizing loss of lean body mass by the animal, preventing a reduction in energy metabolism by an animal, reducing the risk of regaining weight by an animal after weight loss, and ameliorating undesirable animal behaviors associated with reduced caloric intake by intermittently feeding an animal a first diet containing calories that meet the animal&#39;s maintenance energy requirements and a second diet containing calories that do not meet the animal&#39;s maintenance energy requirements. In preferred embodiments, the described feeding pattern and diets are fed in conjunction with one or more weight loss agents.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 13/973,251filed Aug. 22, 2013, which claims the benefit of U.S. ProvisionalApplication No. 61/692,385 filed on Aug. 23, 2012, the disclosures ofwhich are incorporated herein by this reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates generally to methods for preserving lean body massand maintaining higher energy expenditure during weight loss andparticularly to methods for using feeding patterns for for promotingweight loss while preserving lean body mass and maintaining higherenergy expenditure.

2. Description of Related Art

When managing an animal's weight, particularly promoting weight loss, itis a very common practice to reduce caloric intake by restricting theamount of food available to the animal on a chronic and daily basis.Generally, restricting daily food intake chronically causes the animalto be hungry. Hunger is an unpleasant state that often causes one ormore unwanted behaviors by the hungry animal, e.g., begging, seekingfood, binge eating, and the like. In addition, managing weight loss bychronic and daily caloric reduction may cause undesirable results thataffect body composition. Animals that lose weight often lose both fatbody mass and lean body mass and reduce their daily energy expenditure.Reduced daily energy expenditure caused by chronic daily caloricreduction during weight loss makes animals to regain their lost weighteasily and makes it very difficult for the animals to maintain theirideal body weight after weight loss. Therefore, it is frequently moredesirable when losing weight to lose excess fat body mass whilepreserving as much lean body mass as possible and maintaining higherdaily energy expenditure.

Methods for managing weight loss and body mass are known in the art. Forexample, U.S. Pat. No. 8,158,683 discloses using extracts of aronia topromote weight loss. U.S. Pat. No. 8,143,215 discloses promoting weightloss by applying satiety-enhancing or appetite-suppressing compositioncomprising tastant onto food. U.S. Pat. No. 7,989,009 discloses a methodfor promoting weight loss using black tea extract, white tea extract,guarana extract, oolong tea extract, green mate extract, thiamine,choline and N-acetylcysteine. U.S. Pat. No. 6,204,291 discloses aprocess for promoting weight loss in overweight dogs using L-carnitine.U.S. Pat. No. 7,744,930 discloses compositions, methods and kits forenhancing weight loss while inhibiting loss of lean body mass that usesoy protein and chromium in form of salt or chelate. US20040077556A1discloses methods for promoting weight loss and lean muscle mass usingepigallocatechin gallate, caffeine, and 1-tyrosine. U.S. Pat. No.7,850,997 discloses methods of enhancing lean body mass and exerciseperformance using L-arginine alpha amino n-butyrate. U.S. Pat. No.5,804,596 discloses a method for using forskohlin for promoting leanbody mass and treating mood disorders. US20070082026A1 discloses methodsfor reducing caloric intake and controlling weight using dietary fiber.U.S. Pat. No. 8,226,973 discloses using isoflavones for reducingaccumulation of body fat in male mammals. US20110281245A1 discloses asystem for regulating caloric intake by managing food dishes.U20100109876A1 discloses devices, systems, and methods for controllingcaloric intake by modifying consumer behavior. US20030072846A1 disclosespackages useful for controlling dietary caloric intake. US20100126588A1discloses a programmed intermittent automatic watering system foranimals.

These methods are often at least partially effective for managing weightloss and/or lean body mass and related conditions. However, thesemethods may still result in reduced daily expenditure, and hunger andits undesirable behavioral side effects. There is, therefore, a need fornew methods for promoting weight loss, particularly while preservinglean body mass and maintaining higher energy expenditure, that avoid, atleast in part, the undesirable behaviors and reduced daily energyexpenditure associated with weight loss achieved by reducing dailycaloric intake chronically.

SUMMARY OF THE INVENTION

It is, therefore, an object of the invention to provide methods forpreserving lean body mass during weight loss.

It is another object of the invention to provide methods for maintaininghigher energy expenditure during weight loss.

It is another object of the invention to provide methods for avoiding atleast some of the undesirable animal behaviors associated with weightloss achieved by reducing caloric intake.

It is another object of the invention to provide methods for reducingthe risk of regaining weight after a weight loss.

One or more of these and other objects are achieved using novel methodsfor preserving lean body mass during weight loss by an animal,preventing a reduction in daily energy expenditure by an animal,reducing the risk of regaining weight by an animal after weight loss,and ameliorating undesirable animal behaviors associated with reducedcaloric intake. The methods involve intermittently feeding an animal afirst diet containing calories that meet the animal's maintenance energyrequirements and a second diet containing calories that do not meet theanimal's maintenance energy requirements or intermittently feeding ananimal a first diet containing calories that do not meet the animal'smaintenance energy requirements and a second diet containing caloriesthat meet the animal's maintenance energy requirements. Surprisingly,the animal loses essentially the same amount of weight as if the animalhad been fed only the diet that does not meet the animal's maintenanceenergy requirements on a continuous and daily basis. Further, theanimal's behavior is more desirable when fed using the feeding pattern,e.g., there is less begging for food, seeking food, binge eating,voracious eating, anxiety, aggression, depression, excessivevocalization, and the like. Similarly, functions often associated withweight loss are beneficially affected, e.g., preventing or minimizingloss of lean body mass by the animal while the animal is losing weightdue to reduced caloric intake, preventing a reduction in energymetabolism by an animal while the animal is losing weight due to reducedcaloric intake, reducing the risk of regaining weight by an animal afterthe animal has lost weight.

Other and further objects, features, and advantages of the presentinvention will be readily apparent to those skilled in the art.

DETAILED DESCRIPTION OF THE INVENTION Definitions

The term “animal” means a human or other animal that can benefit fromone or methods for promoting weight loss by an animal, promoting weightloss by an animal while preventing or minimizing loss of lean body massby the animal, preventing a reduction in energy metabolism by an animal,reducing the risk of regaining weight by an animal after weight loss,and ameliorating undesirable animal behaviors associated with reducedcaloric intake, including avian, bovine, canine, equine, feline,hicrine, murine, ovine, and porcine animals.

The term “companion animal” means domesticated animals such as cats,dogs, rabbits, guinea pigs, ferrets, hamsters, mice, gerbils, horses,cows, goats, sheep, donkeys, pigs, and the like.

The term “intermittent period(s)” or “intermittently” means a firstperiod and a second period of the same of different durations of timethat reoccur at defined intervals. For example, daily intermittentperiods would involve doing one act for one day, doing a different acton the following day, and possibly repeating the pattern for as many twoday periods as needed or desirable. Similarly, one act such as feedingan animal could be done for a week and a second act such as feeding ananimal a different diet could be done for two weeks, and the cyclerepeated for a year or for the lifetime of the animal. The same wouldapply for periods of multiple days, weeks, months, quarters, years, andthe like, e.g., daily, every other day, every other three days, everyother four days, every other five days, every other six days, weekly,every other week, every other two weeks, every other three weeks,monthly, every other month, quarterly, yearly, and the like.

The term “in conjunction” means that an animal is fed for a first perioda first diet containing calories that meet the animal's maintenanceenergy requirements and fed for a second period a second diet containingcalories that do not meet the animal's maintenance energy requirementsaccording to the invention and the animal is administered a differentcompound, composition, or other agent (1) together in dietarycomposition or (2) separately at the same or different frequency usingthe same or different administration routes at about the same time orperiodically. “Periodically” means that the agent is administered on adosage schedule acceptable for a specific agent and that the food is fedto an animal routinely as appropriate for the particular animal. “Aboutthe same time” generally means that the food and agent are administeredat the same time or within about 72 hours of each other. “Inconjunction” specifically includes administration schemes wherein agentis administered for a prescribed period and the dietary compositions ofthe invention are administered indefinitely.

The term “complete and balanced” when referring to a food compositionmeans a food composition that contains all known required nutrients inappropriate amounts and proportions based on recommendations ofrecognized authorities in the field of animal nutrition, and aretherefore capable of serving as a sole source of dietary intake tomaintain life or promote production, without the addition ofsupplemental nutritional sources. Nutritionally balanced pet food andanimal food compositions are widely known and widely used in the art,e.g., complete and balanced food compositions formulated according tostandards established by the Association of American Feed ControlOfficials (AAFCO).

The term “single package” means that the components of a kit arephysically associated in or with one or more containers and considered aunit for manufacture, distribution, sale, or use. Containers include,but are not limited to, bags, boxes, cartons, bottles, packages of anytype or design or material, over-wrap, shrink-wrap, affixed components(e.g., stapled, adhered, or the like), or combinations thereof. A singlepackage may be containers of individual dietary compositions of theinvention physically associated such that they are considered a unit formanufacture, distribution, sale, or use.

The term “virtual package” means that the components of a kit areassociated by directions on one or more physical or virtual kitcomponents instructing the user how to obtain the other components,e.g., a bag or other container containing one component and directionsinstructing the user to go to a website, contact a recorded message or afax-back service, view a visual message, or contact a caregiver orinstructor to obtain instructions on how to use the kit or safety ortechnical information about one or more components of a kit.

The term “about” means plus or minus 20%, preferably plus or minus 10%,more preferably plus or minus 5%, most preferably plus or minus 2%.

All percentages expressed herein are by weight or amount of the totalweight or amount of the composition unless expressed otherwise.

The invention is not limited to the particular methodology, protocols,and reagents described herein because they may vary. Further, theterminology used herein is for the purpose of describing particularembodiments only and is not intended to limit the scope of the presentinvention.

As used herein, the singular form of a word includes the plural, andvice versa, unless the context clearly dictates otherwise. Thus, thereferences “a”, “an”, and “the” are generally inclusive of the pluralsof the respective terms. Similarly, the words “comprise”, “comprises”,and “comprising” are to be interpreted inclusively rather thanexclusively. Likewise the terms “include”, “including” and “or” shouldall be construed to be inclusive, unless such a construction is clearlyprohibited from the context. Similarly, the term “examples,”particularly when followed by a listing of terms, is merely exemplaryand illustrative and should not be deemed to be exclusive orcomprehensive.

Unless defined otherwise, all technical and scientific terms and anyacronyms used herein have the same meanings as commonly understood byone of ordinary skill in the art in the field of the invention. Althoughany compositions, methods, articles of manufacture, or other means ormaterials similar or equivalent to those described herein can be used inthe practice of the present invention, the preferred compositions,methods, articles of manufacture, or other means or materials aredescribed herein.

All patents, patent applications, publications, and other referencescited or referred to herein are incorporated herein by reference to theextent allowed by law. The discussion of those references is intendedmerely to summarize the assertions made therein. No admission is madethat any such patents, patent applications, publications or references,or any portion thereof, are relevant prior art for the present inventionand the right to challenge the accuracy and pertinence of such patents,patent applications, publications, and other references is specificallyreserved.

The Invention

In one aspect, the invention provides methods for at least one ofpreserving lean body mass and preventing or minimizing loss of lean bodymass during weight loss by animals, preventing a reduction in energymetabolism and maintaining a higher daily energy expenditure duringweight loss by animals, reducing the risk of regaining weight by animalsafter weight loss, and ameliorating undesirable animal behaviorsassociated with reduced caloric intake. The methods comprise two feedingperiods: caloric reduction period and caloric maintenance period. Duringthe caloric maintenance period, the animals are fed a diet containingcalories that meet the animals' maintenance energy requirements. Duringthe caloric reduction period, the animals are fed with a diet containingcalories that do not meet the animals' maintenance energy requirements.The invention is based upon the unexpected discovery that animals fedintermittent feeding patterns will preserve and maintain lean body massand maintain a higher energy expenditure while losing same amount ofweight as the animals fed low caloric diets continuously, in addition,the animal's behavior will be more desirable, e.g., the animals will notbeg for food as often or at all or engage in binge eating as often or atall. Further, when fed according to the invention, the animals will loseweight while preserving lean body mass, retaining energy metabolismcharacteristic animals that are not losing weight, and not regainingweight that has been lost as a result of reduced caloric intake.Additionally, the methods ameliorate undesirable animal behaviorsassociated with hunger that results from reduced caloric intake, e.g.,begging for food, seeking food, binge eating, voracious eating, anxiety,aggression, depression, excessive vocalization, and the like.

While feeding for a the caloric reduction period and for a caloricmaintenance period as described is often sufficient, the preferredmethods require that the feeding pattern be repeated for at least twocycles, for several cycles, for as long as the animal benefits from thefeeding pattern (e.g., achieves a desired weight loss), or for the lifeof the animal.

In various embodiments, the caloric reduction period and the caloricmaintenance period are periods of the same duration or periods of adifferent duration, e.g., the caloric reduction period is a one dayperiod and the caloric maintenance period is a two day period.Preferably, the caloric reduction period and the caloric maintenanceperiod are intermittent periods of the same duration.

Generally, the caloric reduction diet contains fewer calories than thecaloric maintenance diet in any number of calories sufficient tomaintain a higher energy expenditure during weight loss, preserve leanbody mass during weight loss, or achieve any related or associatedbenefit described herein. Preferably the caloric reduction diet containsfrom five percent (5%) to ninety percent (90%) fewer calories than thecaloric maintenance diet, more preferably from ten percent (10%) toseventy percent (70%), most preferably from twenty percent (20%) toforty (40%). In various embodiments, the caloric reduction diet containsat least five percent (5%), ten percent (10%), fifteen percent (15%),twenty percent (20%), twenty-five percent (25%), thirty percent (30%),forty percent (40%), or fewer calories than the caloric maintenancediet. In specific embodiments, the caloric reduction diet contains lesscalories than the caloric maintenance diet by in amounts of five percent(5%), ten percent (10%), fifteen percent (15%), twenty percent (20%),twenty-five percent (25%), thirty percent (30%), forty percent (40%),fifty percent (50%), sixty percent (60%), seventy percent (70%), eightypercent (80%), ninety percent (90%) or an amount between the givenpercentages. In certain embodiments, the caloric reduction diet containsfewer calories than the caloric maintenance diet in amounts of fromabout 5% to about 95% of the calories needed to meet the animal's dailymaintenance requirement for energy, preferably from about 10% to about80%, most preferably from about 15% to about 60%. Any suitable amount isacceptable depending upon the desired results.

In one embodiment, the methods of the invention are implemented inconjunction with the administration of one or more weight loss agents.Any weight loss agent that is compatible with the feeding patterns ofthe invention can be used in the invention. In various embodiments, theweight loss agent is one or more of carnitine, isoflavones, pyruvate,fish oil, DHA, EPA, fibers, calcium, resistant starch, medium chaintriglycerides, green tea extract, phentermine, diethylpropion, orlistat,sibutramine, megestrol, phenylpropanolamine, oxandrolone,oleoylethanolamide, probiotics that promote weight loss, ephedra,conjugated linoleic acid, glucomannan, and the like.

Preferably, the methods are useful for managing weight loss and relatedfunctions described herein for companion animals, particularly thosewhose diet is controlled by an owner or caregiver. Most preferably, theanimals are dogs and cats.

In a further aspect, the invention provides kits suitable forimplementing the methods of the invention. The kits comprise in separatecontainers in a single package or in separate containers in a virtualpackage, as appropriate for the kit component, (1) a complete andbalanced first food composition containing calories that meet ananimal's maintenance energy requirements; (2) a complete and balancedsecond food composition containing calories that do meet the animal'smaintenance energy requirements; and (3) instructions for using the foodcompositions for at least one of promoting weight loss by an animal,promoting weight loss by an animal while preventing or minimizing lossof lean body mass by the animal, preventing a reduction in energymetabolism by an animal, reducing the risk of regaining weight by ananimal after weight loss, and ameliorating undesirable animal behaviorsassociated with reduced caloric intake by feeding the animal for a firstperiod the first food composition and feeding the animal for a secondperiod the second food composition. In certain embodiments, the kitsfurther comprise one or more of one or more weight loss agents.

When the kit comprises a virtual package, the kit is limited toinstructions in a virtual environment in combination with one or morephysical kit components. Generally, the kit contains the foodcompositions and other physical components in amounts sufficient toimplement the methods of the invention and the virtual package containsthe instructions relating to using the physical components to implementthe methods of the invention.

In another aspect, the invention provides a means for communicatinginformation about or instructions for one or more of preventing orminimizing loss of lean body mass during weight loss by the animal,preventing a reduction in energy metabolism during weight loss by ananimal, reducing the risk of regaining weight by an animal after weightloss, and ameliorating undesirable animal behaviors associated withreduced caloric intake by feeding the animal for caloric maintenanceperiod a caloric maintenance diet containing calories that meet theanimal's maintenance energy requirements and feeding the animal for acaloric reduction period a caloric reduction diet containing caloriesthat do not meet the animal's maintenance energy requirements, andoptionally a weight loss agent. The means comprises a document, digitalstorage media, optical storage media, audio presentation, or visualdisplay containing the information or instructions. In certainembodiments, the communication means is a displayed web site, visualdisplay, brochure, product label, package insert, advertisement,handout, public announcement, audiotape, videotape, DVD, CD-ROM,computer readable chip, computer readable card, computer readable disk,computer memory, or combination thereof containing such information orinstructions.

Useful information includes one or more of (1) recommended feedingschedules for the animal, particularly based on the animal's species andbody condition (e.g., overweight or obese), (2) recommended weight lossagents to be administered in conjunction with the use of the recommendedfeeding pattern, and (3) contact information for animals or theircaregivers to use if they have a question about the invention and itsuse.

EXAMPLES

The invention can be further illustrated by the following examples,although it will be understood that these examples are included merelyfor purposes of illustration and are not intended to limit the scope ofthe invention unless otherwise specifically indicated.

Example 1

Overweight cats were randomized into two (2) groups with 15 cats pergroup based on baseline body weight, percent body fat, and maintenanceenergy requirements (MERs).

One group of cats (continuous caloric reduction group; CCR) was fed 75%of their MERs for three months. One group cats (intermittent caloricreduction group; ICR) During each of the three months, cats in the ICRgroup were fed 75% of their MERs for two weeks (caloric reductionperiod) and then 100% of their MERs for two weeks (caloric maintenanceperiod), and the pattern was repeated for three months. The cat's bodycompositions were determined by no-invasive QMR technology. The resultsare shown in Table 1, Tabel 2 and Table 3

TABLE 1 Daily caloric intake (g) during the weight loss % higher caloricintake Month CCR ICR of ICR over CCR 1 53.58 60.82 14 2 55.44 61.60 11 356.08 62.32 11 Average 55.03 61.58 12

TABLE 2 Changes in Lean Body Mass CCR ICR Lean body mass −25  181 changein 1^(st) month (g) Average lean body 71 135.3 mass change in 3 months(g/month)

TABLE 3 Changes in Body Fat and Body Weight CCR ICR Body fat change in1^(st) −257 −330 month (g) Average body fat −417 −433 change in 3 months(g/month) Body weight change −360 −342 in 1^(st) month (g) Average bodyweight  591  532 change in 3 months (g)

Referring to the results, the data show that cats in both groups lostidentical body weight and body fat during the experiment even thoughcats in the ICR group ate 12% more calories than the cats in the CCRgroup, indicating that the energy expenditure of the cats in the ICRgroup was at least 12% higher than that of the cats in the CCR group. Inother words, cats in the CCR group reduced their daily energyexpenditure by at least 12% to compensate for the chronic caloricreduction during the weight loss. However, cats in the ICR group gained181 g lean body mass while the cats in the CCR group lost 26 g lean bodymass at the end of one month of weight loss. During the three months ofweight loss, the cats in the ICR group gained an average of 135 g leanbody mass, while the cats in the CCR group only gained an average of 71g lean body mass.

In the specification, there have been disclosed typical preferredembodiments of the invention. Although specific terms are employed, theyare used in a generic and descriptive sense only and not for purposes oflimitation. The scope of the invention is set forth in the claims.Obviously many modifications and variations of the invention arepossible in light of the above teachings. It is therefore to beunderstood that within the scope of the appended claims the inventionmay be practiced otherwise than as specifically described.

What is claimed is:
 1. A method for at least one of promoting weightloss by an animal, promoting weight loss by an animal while minimizingloss of lean body mass by the animal, minimizing a reduction in energymetabolism by an animal, reducing the risk of regaining weight by ananimal after weight loss, and ameliorating undesirable animal behaviorsassociated with reduced caloric intake, the method comprising: feedingthe animal for a first period a first diet containing calories that meetthe animal's maintenance energy requirements; and feeding the animal fora second period a second diet containing calories that do not meet theanimal's maintenance energy requirements; wherein the first period andthe second period are periods of different durations and wherein thefirst period and the second period are independently selected from thegroup consisting of two days, three days, four days, five days, sixdays, a week, two weeks, and three weeks.
 2. The method of claim 1wherein the feeding for the first period and the feeding for the secondperiod are repeated.
 3. The method of claim 2 wherein the first periodand the second period are intermittent periods.
 4. The method of claim 1wherein the second diet contains at least five percent (5%) fewercalories than the first diet.
 5. The method of claim 1 wherein thesecond diet contains at least ten percent (10%) fewer calories than thefirst diet.
 6. The method of claim 1 wherein the second diet contains atleast twenty percent (20%) fewer calories than the first diet.
 7. Themethod of claim 1 wherein the second diet contains from about 5 to about95% of the calories needed to meet the animal's minimum dailyrequirement for energy.
 8. The method of claim 1 wherein the second dietcontains from about 10 to about 80% of the calories needed to meet theanimal's minimum daily requirement for energy.
 9. The method of claim 1wherein the second diet contains from about 15 to about 60% of thecalories needed to meet the animal's minimum daily requirement forenergy.